CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Afatinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01396265
NCT01396265Phase 1Completed

Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone and After Multiple Doses of Rifampicin - an Open-label, Two-period, Fixed Sequence Clinical Phase I Trial in Healthy Male Volunteers

Boehringer Ingelheim·interventional·Posted Jul 18, 2011·Updated Jun 9, 2014

In Brief

A Phase 1 clinical trial evaluating Afatinib and Rifampicin for Healthy. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.0 years ago

Interventions

Afatinibdrug

single dose

Afatinibdrug

single dose

Rifampicindrug

multiple doses